Growth Study Using Else Toddler Nutritional Drink vs. a. Dairy Based Toddler Drink (Control) in Healthy Toddlers

Not Applicable

Recruiting

• Conditions: Weight Gain
• Interventions: Other: Plant based toddler nutrition; Dietary Supplement: Dairy based toddler nutrition

• Registration Number: NCT05576870
• Lead Sponsor: Else Nutrition GH Ltd

Brief Summary

The aim of the study is to investigate the growth of healthy toddlers fed with Toddler almond based nutritional drink (test) vs. a. formula that has been shown to support growth (control) in Healthy Toddlers

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-10
• Study Start: 2022-10-01
• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-08
• Last Update Submitted: 2022-10-08
• Study First Posted: 2022-10-13
• Last Update Posted: 2022-10-13
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

1. Gestational age between ≥37 weeks + 0 days and ≤41 weeks + 6 days,
2. Weight for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
3. Length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
4. Weight for length for age ≥ 5th and ≤ 95th percentile for age according to sex-specific World Health Organization (WHO) growth charts
5. Consuming and tolerating a cow's milk and almond at time of enrollment (at least 3 age appropriate portions)
6. Consuming and tolerating almond on more than one occasion in age appropriated doses, to ensure no reaction to study formula e.g. 2 teaspoons almond butter in one portion or 500 ml/16 fl oz per day

Exclusion Criteria

1. Toddler with any positive food allergy test food allergy or intolerance to any foods
2. Participants are under ongoing medical care of a pediatrician which according to the parents will make it difficult to complete the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plant based toddler nutrition	Plant based toddler nutrition	Plant based toddler nutrition based on almond and buckwheat drink
Dairy based toddler nutrition	Dairy based toddler nutrition	Commercially available dairy based toddler nutrition drink

Primary Outcome Measures

Name	Time	Method
height velocity	4 months
Weight gain	4 months

Secondary Outcome Measures

Name	Time	Method
Daily intake	4 months	Volume of consumption will be recorded in fluid oz or ml per day

Trial Locations

Locations (1)

Children's Hospital of Colorado; 🇺🇸 Denver, Colorado, United States